Ohio

FDA UDI

Class I (US FDA UDI)

by Ohio Medical LLC

Identity

Trade Name: Ohio FDA UDI
Generic Name: General-gas low pressure tubing, reusable FDA UDI
Device Name: 10' HOSE ASMBLY US AIR CF*CM COND 1/4" FDA UDI
Model / Reference: HS-10UA-CFCMC4 FDA UDI
Description: 10' HOSE ASMBLY US AIR CF*CM COND 1/4" FDA UDI

Identifiers

Catalog Number: HS-10UA-CFCMC4 FDA UDI
Primary DI / UDI-DI: 00628101552787 FDA UDI
FDA Product Code: BYX FDA UDI
GMDN Term: General-gas low pressure tubing, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 868.5860 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: General-gas low pressure tubing, reusable

Ohio Ohio Medical, LLC's General-gas low pressure tubing is a reusable device used for the delivery of compressed medical gas in non-sterile environments. This tubing is designed for use with various medical gases, including oxygen, nitrogen, and carbon dioxide. It features a flexible length and a working pressure range of 3-15 bar, making it suitable for a wide range of respiratory medical devices. The tubing is available in standard coil lengths and is not colour-coded. Ohio Medical's General-gas low pressure tubing is compatible with implantable devices, such as oxygen concentrators.

Similar devices

Also classified as General-gas low pressure tubing, reusable.

Ohio — Ohio Medical LLC · Class I
Ohio — Ohio Medical LLC · Class I
Ohio — Ohio Medical LLC · Class I
Ohio — Ohio Medical LLC · Class I
Ohio — Ohio Medical LLC · Class I
Ohio — Ohio Medical LLC · Class I
Ohio — Ohio Medical LLC · Class I
Ohio — Ohio Medical LLC · Class I

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: Ohio Medical LLC

Sources (1)

FDA UDI 3ae5c053-3723-464b-8875-24cc2ed957aa 35 fields · synced Jul 2, 2026